Duns Number:017524666
Device Description: Premium PGA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Undyed, 27"
Catalog Number
-
Brand Name
Premium UNIFY PGA Sutures
Version/Model Number
PXXLU-G227T40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073614,K161629,K200392,K073614,K161629,K200392
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
4bc62487-3b7c-4e51-8a83-ba7ac5a25301
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
August 13, 2018
Package DI Number
10814639023920
Quantity per Package
12
Contains DI Package
00814639023923
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |